TREVO NXT 4MM X 28MM - US

Additional Manufacturer Narrative

H4 MANUFACTURING DATE ¿ ADDED. H3 DEVICE EVALUATED BY MFG ¿UPDATED. H3 SUMMARY ATTACHED - UPDATED. D4 EXPIRATION DATE - ADDED. D9 PRODUCT AVAILABLE TO STRYKER ¿ UPDATED. D9 RETURNED TO MANUFACTURER ON ¿UPDATED. THE DEVICE WAS RETURNED AND THE LOT NUMBER WAS CONFIRMED WITH THE PACKAGING RETURNED WITH THE DEVICE. DURING VISUAL INSPECTION, THE RETRIEVER SHAPED SECTION WAS NOTED TO HAVE KINKED STRUTS AND A BROKEN STRUT. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE DAMAGE NOTED WOULD HAVE CAUSED FURTHER DAMAGE DURING TESTING. BASED ON THE RESULTS OF THE DHR REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. COMPLAINT INFORMATION STATES THAT, ALTHOUGH VERY STRONG RESISTANCE WAS FELT WHEN ADVANCING INSIDE TRAK21, THERE WAS A THOUGHT THAT THE REASON WAS THAT ICA WAS HIGHLY MEANDERING, SO IT WAS ADVANCED AS IT WAS AND IMPLEMENTED 1 PASS. WHEN THE COLLECTED THROMBUS WAS VISUALLY CONFIRMED, IT WAS CONFIRMED THAT A PART OF THE SR WAS DAMAGED AND ONE WIRE WAS PROTRUDING OUTWARD FROM THE STENT. THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT AND THE PATIENTS ANATOMY WAS VERY MEANDERING. IT IS PROBABLE THAT THE DEVICE WAS DAMAGED DURING NAVIGATION THROUGH THE PATIENTS TORTUOUS ANATOMY. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED EVENT OF THE BEING RETRIEVER DIFFICULT/UNABLE TO GO THROUGH CATHETER SHAFT, FRACTURED/BROKEN DURING USE, THE DEVICE BEING DIFFICULT TO ENGAGING TARGET VESSEL AND TO THE ANALYZED RETRIEVER FRACTURED/BROKEN DURING USE AND SHAPED SECTION DAMAGE, AS THIS COMPLAINT APPEARS TO BE ASSOCIATED WITH A PRODUCT THAT MET STRYKER AND DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU, BUT PERFORMANCE WAS LIMITED DUE TO 'PROCEDURAL FACTORS' DURING USE.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE FOR AIS (ACUTE ISCHEMIC STROKE), DISTAL ACCESS CATHETER AND MICROCATHETER WERE USED. BOTH DEVICES WERE NAVIGATED TO ICA (INTERNAL CAROTID ARTERY) BY GUIDEWIRE. THE SUBJECT RETRIEVER WAS THEN ADVANCED AND PASSED THROUGH THE THROMBUS OF M1. PHYSICIAN THEN NOTED THAT THERE WAS STRONG RESISTANCE WHEN ADVANCING SUBJECT RETRIEVER INSIDE THE CATHETER DURING ONE PASS. IT WAS REPORTED THAT PATIENT¿S ICA WAS HIGHLY TORTUOUS. WHEN THE THROMBUS WAS COLLECTED AND VISUALLY CONFIRMED THE PHYSICIAN NOTED THAT THE STENT PORTION OF THE SUBJECT STENT RETRIEVER HAD ONE WIRE BROKEN AND PROTRUDING OUTWARD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WAS NOTED TO THE PATIENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE FOR AIS (ACUTE ISCHEMIC STROKE), DISTAL ACCESS CATHETER AND MICROCATHETER WERE USED. BOTH DEVICES WERE NAVIGATED TO ICA (INTERNAL CAROTID ARTERY) BY GUIDEWIRE. THE SUBJECT RETRIEVER WAS THEN ADVANCED AND PASSED THROUGH THE THROMBUS OF M1. PHYSICIAN THEN NOTED THAT THERE WAS STRONG RESISTANCE WHEN ADVANCING SUBJECT RETRIEVER INSIDE THE CATHETER DURING ONE PASS. IT WAS REPORTED THAT PATIENT¿S ICA WAS HIGHLY TORTUOUS. WHEN THE THROMBUS WAS COLLECTED AND VISUALLY CONFIRMED THE PHYSICIAN NOTED THAT THE STENT PORTION OF THE SUBJECT STENT RETRIEVER HAD ONE WIRE BROKEN AND PROTRUDING OUTWARD. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO CLINICAL CONSEQUENCES WAS NOTED TO THE PATIENT.